The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Eur Heart J Qual Care Clin Outcomes. 2021 Sep 16;7(5):468-475. doi: 10.1093/ehjqcco/qcab042.
Non-valvular atrial fibrillation (AF) greatly increases the risk of ischaemic stroke. For people with contraindications to oral anticoagulation, left atrial appendage occlusion (LAAO) provides a non-pharmacological management alternative. The aim of this study was to measure the procedural safety and longer-term effectiveness of LAAO for AF in a UK setting.
This was a prospective, single-armed registry of patients with AF for whom anticoagulation was unsuitable. Registry data were collected between October 2014 and April 2018 and linked to routine data sources for follow-up. Data from 583 LAAO procedures were entered into the registry, of which 537 (from 525 patients) were eligible for inclusion (median CHA2DS2-VASc score 4). A closure device was successfully implanted in 93.4% of cases, with a procedural success rate (device implanted without major complication) of 88.9%. Five patients (1.0%) died in hospital. During follow-up [median 729 (Q1:Q3, 523:913) days] 45 patients experienced neurological events; 33 of which were ischaemic. The ischaemic neurological event rate was 3.3 (1.6-5.0)% at 1 year (n = 387) and 7.0 (4.3-9.6)% at 2 years (n = 196). There were significant improvements in overall patient health (via Visual Analogue Scale) measured at 6 weeks and 6 months, but no significant improvements observed in patient utility over time.
The findings of our study suggest that LAAO is not without procedural risk, but that this risk may be justified in high-risk patients with AF who cannot take an anticoagulant. Moreover, the data do not provide support for more widespread use of LAAO as the complication rate was relatively high and would be difficult to justify in many patients with AF who tolerate anticoagulation.
非瓣膜性心房颤动（AF）大大增加了缺血性中风的风险。对于不能接受口服抗凝治疗的患者，左心耳封堵术（LAAO）提供了一种非药物治疗的选择。本研究的目的是在英国环境下测量 LAAO 治疗 AF 的程序安全性和更长期有效性。
这是一项针对不适合抗凝治疗的 AF 患者的前瞻性、单臂登记研究。登记数据于 2014 年 10 月至 2018 年 4 月期间收集，并与常规数据来源进行了随访。583 例 LAAO 手术的数据被输入到登记处，其中 537 例（来自 525 例患者）符合纳入条件（中位数 CHA2DS2-VASc 评分 4）。93.4%的情况下成功植入了封堵装置，手术成功率（无重大并发症植入装置）为 88.9%。5 例患者（1.0%）在医院死亡。在随访期间[中位数 729（Q1：Q3，523：913）天]，45 例患者发生了神经事件；其中 33 例为缺血性。缺血性神经事件发生率在 1 年时为 3.3（1.6-5.0）%（n=387），2 年时为 7.0（4.3-9.6）%（n=196）。通过视觉模拟量表（VAS）在 6 周和 6 个月时测量的患者整体健康状况有显著改善，但随时间推移，患者效用未见显著改善。
我们的研究结果表明，LAAO 并非没有程序风险，但对于不能服用抗凝药物的 AF 高危患者，这种风险可能是合理的。此外，由于并发症发生率相对较高，并且在许多能耐受抗凝治疗的 AF 患者中难以证明其合理性，因此数据不支持更广泛地使用 LAAO。
